For World Class GMP Calibration

Blue Mountain Regulatory Asset Manager

814.234.2417 | www.coolblue.com 01.BLUE MOUNTAIN QUALITY RESOURCES

In today’s competitive Life Sciences’

marketplace, you are under more

pressure to increase productivity with

substantially less dollars, while still

meeting the tight GMP compliance

requirements. Most importantly,

the products you produce have

to maintain the highest quality.

Blue Mountain understands these

challenges and can help you make a

solid investment with proven results

for a fast return on investment (ROI).

Blue Mountain Regulatory

Asset Manager is the industry

leading calibration software

solution designed specifically

for pharmaceutical, biotech and

medical device companies. Based

on our industry experience and

legacy software, Blue Mountain

RAM has the best in class calibration

functionality so you can get the job

done better and faster, while meeting

GMP compliance.

Blue Mountain Regulatory Asset

Manager’s web-based, state of the

art architecture makes it easy to

implement for one site or across the

entire Enterprise. By standardizing

your calibration management with

Blue Mountain RAM, you can achieve

higher levels of corporate GMP

compliance as well as significantly

increase productivity. Easily integrate

Blue Mountain RAM with other

applications through our API

capability to share data and ultimately

affect your bottom line.

Blue Mountain RAM for Calibration:

Web-based enterprise model

Multi-site proven

Part 11 compliant Work Flow

Highly configurable Work Spaces

Sophisticated Measurement Data

collection capability

814.234.2417 | www.coolblue.com 02.BLUE MOUNTAIN QUALITY RESOURCES

With Blue Mountain RAM, you

can manage the full lifecycle of

calibration from instrument induction

to retirement. Best of all, the system

is completely configurable to your

business processes so you can

manage calibrations in your specific

environment. The combination of

incorporating your business processes

with full electronic signature

functionality allows you to manage

the calibration life cycle with change

control and audit trail traceability.

All of this lets you strengthen your

compliance position and avoid the cost

and issues of noncompliance.

Blue Mountain RAM and the Calibration Life Cycle

Automatically handle OOT events

Measurement Uncertainty calculator

Perform reverse traceability for

Standards

Manage multiple calibration

schedules for a single instrument

Automatic notification of

calibrations coming due

Quantify performance with KPI tools

and reporting functionality

Automating Calibration Management with Part 11 Work Flow

Blue Mountain RAM’s Work Flow functionality can be configured to meet your exact business processes.

Manage the Full Calibration Life Cycle

Go Paperless

Going paperless can seem like a

daunting task, especially if you

have never been through the

process. Questions around, what is

required, how do I meet compliance

requirements and what internal

processes will I have to change, might

discourage the move to a paperless

system. With Blue Mountain RAM, you

can make the paperless vision a reality,

simply and affordably.

Blue Mountain RAM has the complete

capability to make your organization

a paperless one. The software was

designed specifically for Life Sciences’

companies, so Part 11 compliance is

built into the system. By implementing

the paperless functionality, you

will be able to streamline processes

and optimize data utilization for

better productivity.

Blue Mountain RAM and Paperless Benefits

Improve compliance by forcing the

use of standards

Manage work, enforce processes

and mandate electronic signatures

with the Work Flow Tool

Maximize productivity with

electronic notifications

Retrieve data quickly and easily – no

more filing cabinets

Save time with built-in

measurement data calculations

Standardize Across the Enterprise

Within one organization,

assets are managed

by multiple sites, labs and

departments and typically within more

than one software system. Disparate

systems can result in decreased

productivity, non-compliance issues

and ultimately have a negative effect

on your bottom line.

With Blue Mountain RAM,

standardization across the enterprise

is easy and designed so each site

across the enterprise can set-up the

system to meet their unique needs,

including dates and languages, and

still collaborate with one another.

By implementing Blue Mountain

RAM, you can drive productivity and

compliance and, most importantly,

can make your organization

more profitable.

Blue Mountain RAM for the Enterprise

100% web-based

Multiple data sets

Data sharing with API capability

Singular deployment and validation

for all sites

814.234.2417 | www.coolblue.com 03.BLUE MOUNTAIN QUALITY RESOURCES

Mobile for the way you do work!

Your ability to do work

in the field has never

been greater. Blue

Mountain RAM is

wireless capable out of

the box with Internet

Explorer—allowing

calibration work to be

done directly on

the shop floor.

PO Box 830, State College, PA 16804-0830

© 2013 Blue Mountain Quality Resources, Inc.Blue Mountain Quality Resources, Blue Mountain Regulatory Asset Manager are registered trademarks of Blue Mountain Quality Resources, Inc.

Internet Explorer is a registered trademark of Microsoft Corporation. SAP is a registered trademark of SAP.

814.234.2417 | www.coolblue.com 04.BLUE MOUNTAIN QUALITY RESOURCES

Blue Mountain RAM Platform

The Blue Mountain RAM platform

is the starting point for any

implementation. You can choose

a Custom Configuration of the

software or a Template solution

built on industry best practices.

Custom Configuration

Implement the system exactly

as you want - your business

processes and environment.

Best Practices Template

This pre-configured template

is built on GMP best practices

and has rich functionality for

maintaining the asset lifecycle.

Essentials Template

The entry-level system is tightly

locked down and configured

to align with common

GMP practices.

You can enhance your implementation

with our System Add-Ons as well as

integrate with external systems using

our robust API. Our Professional

Services team will work with you

through the entire implementation

process to ensure you get the most

from your investment.

Custom Con�guration & Templates

■ Custom Con�guration

■ Best Practices Template

■ Essentials Template

Services

■ Project Assessment

■ Implementation

■ Validation

■ Data Migration

■ System Integration

■ Training

■ Tech Support/Maintenance

■ Consulting

Blue Mountain RAM Platform

Custom Con�guration Templates Add-Ons

API

Services

Add-Ons

■ Custom Reports

■ Business Intelligence

Engine

■ KPI Dashboard

API

■ SAP Integration

■ ERP Integration

■ LIMS Integration

■ MES Integration

■ Custom Integration

Blue Mountain RAM Platform

Common Platform upon which all

Blue Mountain solutions are built.